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Regulatory & Quality Assurance
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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
We are seeking a Quality Engineer II to support diagnostic reagent manufacturing validation activities
Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. 

  • Author and execute validation protocols and reports (Methods, Equipment, Facilities/Utilities, Raw Materials, Process, Cleaning, Supplier, and Shipping).
  • Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities).
  • Lead cross-functional team to write PFMEAs under limited supervision.
  • Perform process risk assessment for Non-Conformance Events (NCEs).
  • Assist in maintaining validation records.
  • Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects.
  • Propose improvement projects with supporting data, flowcharts, etc.
  • Assist in developing/updating departmental procedures and other controlled documents.
  • Evaluate adequacy of specifications for new or modified process designs under limited supervision.
  • Lead department and cross-department projects under limited supervision.
  • Participate in process design reviews.
  • Assist QE management in Material Review Board (MRB) and Production Response Team (PRT) meetings.
  • Participate in department process improvements goal(s).
  • Assist in development, maintenance, and reporting of department metrics.

  • Proficient in validation methods and evaluation criteria.
  • Experience with process, method, facility and equipment validation.
  • Experience with change control systems.
  • Experience with electronic document management systems.
  • Understanding of basic statistics and acceptance sampling.
  • Experience with PFMEAs.
  • Working knowledge of CDRH, CBER and ISO regulations.
  • Working knowledge of 21 CFR Part 11.


  • Bachelor’s degree in Science.
  •  Five years of experience in a diagnostic, medical device, biotech or pharmaceutical company.

Physical Demands
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

Sit; use hands to finger, handle or feel objects, tools, or controls.

Exposure to moving mechanical parts, vibration and/or moderate noise levels.

Exposure to hazardous chemicals or other materials.

Exposure to blood.

Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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